Nebenwirkungen · Gilenya
Gilenya 0.25 mg hard capsules Gilenya 0.5 mg hard capsules · Abschnitt 4.8 · PDF-Seite 17
HOS-124801 · Präparat HOS-095937
Bradyarrhythmia Initiation of treatment results in a transient decrease in heart rate and may also be associated with atrioventricular conduction delays. In multiple sclerosis clinical studies the maximal decline in heart rate was seen within 6 hours after treatment initiation, with declines in mean heart rate of 12-13 beats per minute for fingolimod 0.5 mg. Heart rate below 40 beats per minute in adults, and below 50 beats per minute in paediatric patients, was rarely observed in patients on fingolimod 0.5 mg. The average heart rate returned towards baseline within 1 month of chronic treatment. Bradycardia was generally asymptomatic but some patients experienced mild to moderate symptoms, including hypotension, dizziness, fatigue and/or palpitations, which resolved within the first 24 hours after treatment initiation (see also sections 4.4 and 5.1).
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